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Form 483

Purcell International Form 483, 2020-03-10

FDA issued a Form 483 to Purcell International on 2020-03-10 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Purcell International · Pleasant Hill, United States · Issued March 10, 2020

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Mar 2020
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Melody M Ragasa-Leong, Jessica J Lee

Inspected site

PIPurcell InternationalPleasant Hill, United States

Inspection team

MMMelody M Ragasa-Leong
JJJessica J Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere